Implantable blood conveying device, manipulating device and coupling device

ABSTRACT

An implantable component is described which is connectable to a manipulating device in a self-retaining manner by a coupling device, which provides a first coupling element and a second coupling element. The implantable component can thus be really positioned by the manipulating device which can, for example, already be connected to the implantable component before a therapeutic procedure and can be separated therefrom again after the surgical procedure. This is in particular advantageous with minimally invasive procedures.

FIELD OF THE DEVICE

The device is in the field of medical engineering, in particular implantmedicine, and in particular relates to the possibilities of implantingcomponents with a minimal effort using minimally invasive procedures.

BACKGROUND OF THE DEVICE

Implant medicine allows the use of the most varied units and elements ina patient's body for the replacement of specific organs and body partsin a temporary or permanent manner or the insertion of specific units tosupport bodily functions.

Such units can usually be put in place in a simple manner with a largeopening of the patient's body, but with considerable surgical traumaarising. The reduction of surgical trauma requires smaller procedures,with the openings for introducing components into the body in part onlybeing a little larger or even smaller, with an elastic widening, thanthe components to be introduced. Corresponding units can be introducedin parts and can also be assembled inside the body.

The minimal invasive introduction often does not allow the directhandling of components by hand so that additional instruments such asforceps are used. However, the use of such holding instruments is alsonot always simple. The components to be implanted are frequentlydesigned as small as possible and also rounded so as to provide aslittle irritation as possible in the body, in particular with cardiacassist systems having a plurality of parts which conduct blood. On theother hand, it brings along a difficult management by correspondingholding instruments such as forceps. A precisely targeted positioning orthe assembly of individual components in the patient's body is alsodifficult. This can in particular be the case with cardiac assistsystems when pumps, canulae and drive components have to be assembled.

Various aids are known from the prior art for implanting parts ofcardiac assist systems into a patient's body.

An apparatus is known from PCT/US2008/081082 having an anchor which canbe inserted close to the heart and which is connected to a guide fiber.A tubular hollow body is displaceable toward the anchor on the guidefiber and can be held there by means of a magnetic device.

A handling device for a canula is known from WO 2009/029387 A1 which hasa guide body extending through the interior of the canula and a holdingbody which can be expanded radially in the manner of a cushion to holdthe canula.

Said holding body can be expanded so far that it jams in the interior ofthe canula.

SUMMARY OF THE DEVICE

Against the background of the prior art, it is the underlying object ofthe device to provide a blood-conductive implantable component whicheffectively cooperates with a corresponding manipulating device to allowa reliable insertion and positioning in a patient's body with minimallyinvasive surgery. A further subject of the solution is a correspondingmanipulating device, a coupling device for the mechanical coupling of animplantable component with a manipulating device as well as the systemcomprising the component and the manipulating device and a correspondingmethod for connecting the components to a manipulating device and forseparating them.

The object is achieved by an implantable component in accordance withthe invention, by a manipulating device for handling such a component,by a coupling device for the mechanical coupling of a component with amanipulating device, by a system comprising at least one implantablecomponent and at least one manipulating device, by a correspondingmethod for connecting an implantable component to a manipulating deviceand by a method for separating an implantable component from amanipulating device.

The device relates to an implantable component which bounds ablood-conductive passage within a human or animal body in operation,which in particular forms a part of a blood conveying device and whichhas a coupling element which is configured for mechanical coupling to amanipulating device, wherein the coupling between the manipulatingdevice and the component allows a manipulation in all spatialdirections. This means that the component is displaceable in freelyselectable spatial directions depending on the necessities in handling.In addition, the component can also be rotatable and/or pivotable aboutdifferent axes, in particular a plurality of axes. These axes can extendinside and/or outside of the implantable component and, for example,also through a coupling element. A fixed-angle connection of thecoupling elements to one another in one or more planes, in particular atall sides, can in particular be provided for this purpose.

Such a component can generally be any component usable in a patient'sbody, in particular a part of a cardiac assist system, a blood pump, ablood pump for coupling to a heart, a valve, a canula, a catheter,corresponding connection systems between these components as well as amedicine dispensing pump.

Many of these components are equipped with particularly smooth androunded surfaces to avoid lesions on the insertion into or dwelling in abody. This makes the handling by the hand of the surgeon or by graspingforceps difficult. For this reason, in accordance with the invention, acoupling element is provided which is configured for the mechanicalcoupling of a manipulating device to the component. In this connection,a surgical instrument is, for example, understood as a manipulatingdevice which has, for example, a handle at the proximal end facing thesurgeon as well as a shaft and a distal end which is connectable to thecoupling element of the component.

For this purpose, a further coupling element which is connectable to thefirst coupling element fastened to the implantable component orintegrated therein can be provided at the distal end of the manipulatingdevice.

A mechanical coupling is thus provided which allows a reliablemanipulation of the implantable component from outside the body by meansof the manipulating device both on the first implantation and later.

More than one coupling element can also be arranged at the implantablecomponent to be able to use a plurality of manipulating devices or adivided manipulating device which can, in simplified terms, also be usedin this case for the alignment of the implantable component. Theplurality of coupling elements at the implantable component are spacedapart from one another at the surface of the implantable component forthis purpose and can also be used to be able to select the most suitableaccess path depending on the implantation site.

The coupling element at the component is furthermore configured for theself-retaining coupling of a manipulating device. This means that theimplantable component does not have to be held tight permanently byactuation of the manipulating device as is the case, for example, withvarious surgical forceps. The coupling between the component and themanipulating device is advantageously designed as self-retaining so thatthe manipulating device can also be left out of consideration at timesby the surgeon without the coupling being released.

The coupling devices are advantageously configured so that correspondingcoupling forces are only developed between the coupling elements, forexample by elastic deformation of one of the coupling elements, withoutforces being transmitted via the shaft of the manipulating device forthis purpose.

The surgeon can hereby concentrate sequentially on differentmanipulating devices and it is ensured that the relative position of amanipulating device to the implantable component is fixed in a stableand unmovable manner.

The coupling element can be integrated in the component or fixedlyconnected thereto. In this respect, the coupling between the couplingelement fastened to or integrated in the component and the manipulatingdevice should advantageously also be releasable again in a particularlyeasy manner so that the manipulating device can be easily removed fromthe patient's body after the positioning and assembly of the implantablecomponent.

The coupling element itself can in this respect, for example, be formedas an internal thread in the implantable component, preferably inside abore and a further coupling element in the form of a threaded spigot canbe screwed into it.

The coupling element can equally be designed as a bore or as a group ofbores in the component into which bolts of a further coupling elementcan be introduced. Corresponding bolts can, for example, comprise metal,but also elastic materials such as rubber or also spring wire which canbe introduced into the corresponding bores in a force-locking manner. Acoupling element can typically also be designed as a groove, forexample, having an undercut, for example, as a dovetail groove, intowhich a body of a further component which is designed in acorrespondingly complementary manner can be inserted.

Bores or blind holes or other openings with or without undercuts canalso form a coupling element, with the respective complementary couplingelement then, for example, being able to have a deformable and/ormovable body having projections and/or latching elements which effect acoupling and which can either be latched by means of an actuation deviceor which can be deformed on the provision of a pulling force and theexceeding of a specific trigger force to separate the coupling elements.For this purpose, for example, one of the coupling elements can at leastpartly comprise an elastomer or a spring.

For example, the manipulating device can include a correspondingcoupling element and additionally a hollow shaft which is coupled to ahandle. The corresponding actuation member for latching noses or forreleasing a screw connection in the region of the coupling between thecoupling elements can be provided within the shaft and the actuationmember can be actuable in the region of the handle of the manipulatingdevice.

It is also conceivable to form a coupling element as a cone which isintegrated in the component, for example, a wall of the component, andinto which a further cone can be pushed which forms a second couplingelement which is connected to a manipulating device. The cone surfacescan, for example, be coupled to one another by a press fit, but also bymeans of adhesive or by a vacuum-tight closure. Skew cone clamps canalso be used for such a connection.

It is moreover conceivable that one or more wrench flats at theimplantable component serve as the coupling element and allow theshape-matched engagement of a corresponding coupling element of themanipulating device.

Provision can also advantageously be made that the correspondingcoupling element at the component side is fastened to the implantablecomponent, for example bonded, welded or soldered thereto or also formedin one part therewith. This can be made, for example, in that a couplingplate having a threaded bore or an eyelet or a solid body, which can inturn have a bore, a groove, wrench flats or cone surfaces, is fastenedto the implantable component.

The coupling element can, for example, also be formed as a smooth,surface-smoothed area onto which a suction cup serving as a secondcoupling element can be placed. The suction cup can, for example, bedirectly aerated and vented through the shaft of the manipulating deviceto which it is connected in order directly to establish and release thecoupling between the coupling elements.

The connection of two smooth coupling surfaces of two coupling elementsby means of an adhesive is also conceivable, with the adhesive beingable to be directly dissolved or embrittled to release the connection.The adhesive can, for example, be made as a thermoplastic which can beliquefied in a short time to separate the coupling elements from oneanother or as a curable resin which can be embrittled by radiationcross-linking, for example by UV light, so that the adhesive bond can beeasily broken.

It is also conceivable to connect the implantable component to acoupling element of the manipulating device in one piece in themanufacture by casting so that the implantable component, the couplingelement connected thereto and at least one part of the manipulatingdevice itself or the total manipulating device are made in one piece,for example in an injection molding process.

A desired break point is then provided between the coupling elements ofthe implantable component and of the manipulating device to be able toremove the manipulating device after the positioning of the implantablecomponent by breaking the coupling between the coupling elements.

A magnet or a ferromagnetic workpiece can, for example, be provided as acoupling element at the component side which is arranged at the outerside or in the interior of the component and which cooperates with amagnet or with a ferromagnetic part of the manipulating device for thecoupling. A part of a motor or of a rotor can also act as a magnet inthe component, for example. A fitting surface can be provided at theouter side of the component for the coupling of the manipulating device.One of the magnets of the coupling device can be designed as aswitchable electromagnet. A corresponding fitting surface can bedesigned, for example when it forms a part of the coupling element atthe component side, as a mechanical catching device for the secondcoupling element associated with the manipulating device and can have arecess which has introduction chamfers or similar introduction aids forthe second coupling element. An introduction chamfer can, for example,be integrated in an introduction cone, a hollow sphere or another recesstapering toward the component interior. The second coupling element canoptionally have a complementary geometrical shape.

In particular when the first coupling element is formed as a fittingsurface, particularly with an introduction chamber, and in particularwhen the fitting surface itself is not located in direct proximity to aferromagnetic body of the component, but also in all other casesdescribed here, the component can be designed such that the contour ofthe fitting surface can be reproduced by imaging processes, for exampleX-rays or ultrasound. This is e.g. possible by a metal surface cover ofthe component in the region of the fitting surface or by a marker bodywhich has a higher density than the wall of the component and which isintegrated in the component in direct proximity of the fitting surfaceor with a recognizable geometrical relation to the fitting surface. Acoupling can thus be established more easily and without visual contactbetween a manipulating device having a ferromagnetic coupling elementand the component on a further invention which may become necessaryafter the first implantation.

An eyelet can also be provided at an outer surface of the component as acoupling element through which eyelet a thread is guided which serves asa coupling element of the manipulating device. Such a design is inparticular of interest when a part of a longer flexible component suchas a tubular canula should be drawn from an entry site to a target site.The coupling can then be easily separated by separation of the thread.

The associations with the component, on the one hand, and with themanipulating device, on the other hand, can generally be swapped over inthe above-described complementary coupling elements.

A coupling device in accordance with the invention correspondinglyprovides a first coupling element which is associated with theimplantable component as well as a second coupling element which isassociated with the manipulating device, with the coupling elementsbeing connectable or connected to one another in a force-locking mannerand/or in a shape-matching manner and/or with material continuity.

The coupling device is in this respect advantageously configured so thatthe coupling is kept stable without an external effect.

If the coupling comprises a connection with material continuity betweenthe first component and the second component, said connection can beseparated by breaking, cutting or changing the mechanical materialproperties of at least one part of the coupling device. The change inthe mechanical material properties is understood, for example, as anembrittlement by radiation effect or thermal effect or a melting of apart of the coupling or a vaporizing, for example by the effect of alaser.

The device also relates, in addition to an implantable component, amanipulating device and a coupling device, to a corresponding systemhaving one or more components and one or more manipulating devices whichare correspondingly configured to be couplable in a simpleself-retaining manner by means of the coupling elements. Thecorresponding couplings must also be able to be released again in asimple and gentle manner inside the patient.

The device further also relates to a method of connecting an implantablecomponent to a manipulating device, with the component beingmechanically connected to the manipulating device before theintroduction into the patient's body by means of a self-retainingreleasable coupling device.

This can, for example, already take place in the manufacture of theimplantable component by integration of the coupling device, in that,for example, the component and at least one part of the manipulatingdevice are manufactured in one piece together with the coupling devicein an injection molding process or are connected to one another in ajoining process.

The implantable component can also be releasably screwed, clamped,bonded or latched to the manipulating device, with a respective one ofthe coupling elements cooperating in a complementary manner with theother coupling element and with, for example, a threaded bore beingarranged in the component and a corresponding threaded bolt at themanipulating device and with each of the coupling elements also eachbeing able to be provided in swappable manner at the respective otherpart. If, therefore, for example, an eyelet is provided at theimplantable component and a corresponding hook at the manipulatingdevice, the hook can also be provided at the implantable component andthe eyelet at the manipulating device. This also applies to all otherembodiments of the coupling elements.

If the implantable component and the manipulating device are alreadyconnected to one another before the start of a surgical procedure, thisfacilitates and accelerates the surgical procedure.

The separation of the implantable component from the manipulating devicecan typically only take place after the end of the implantation, forexample by mechanical breaking of the coupling device or by anotherseparation of the coupling device.

The coupling device can be mechanically weakened, for example, beforethe separation, e.g. by cooling, heating, irradiating, bending or bykinking the coupling device.

If the method for separating the implantable component from themanipulating device takes place in manner which does not provide anydisplacement or movement of the manipulating device with respect to thecomponent, this has the advantage that the positioning of the componentdoes not have to be changed again after the end of the surgicalprocedure. A corresponding release of the coupling device can takeplace, for example, by cutting or chemical dissolving, degrading,liquefying or vaporizing of a part of the coupling device.

DESCRIPTION OF THE FIGURES

The device will be shown and described in the following with referenceto an embodiment in a drawing. There are shown

FIG. 1 a representation of an implantable component and of twomanipulating devices in a three-dimensional view;

FIG. 2 schematically in section, a manipulating device, a section of animplantable component and a coupling device;

FIG. 3 a view of a coupling device;

FIG. 4 a coupling device from FIG. 3 in a plan view;

FIG. 5 a further coupling device;

FIG. 6 a coupling device, a section of a component and a manipulatingdevice;

FIG. 7 a section of a component and a coupling device;

FIG. 8 a section of an implantable component;

FIG. 9 a section of an implantable component with a coupling device;

FIG. 10 an alternative coupling device to that shown in FIG. 9;

FIG. 11 a section of a component with a coupling device;

FIG. 12 a part of an implantable component in a section with a couplingdevice;

FIG. 13 a further alternative of a coupling device with a section of animplantable component; and

FIG. 14 an alternative of a coupling device with an inflatable couplingelement.

DETAILED DESCRIPTION OF THE DEVICE

FIG. 1 shows schematically and in a stylized fashion an implantablecomponent 1, which, for example, represents a pump for conveying bloodas a part of a cardiac assist system, having a cylindrical outer wall 2of a pump housing and a axial rotor, which is not shown in detail,supported in the hollow cylinder.

A coupling element 4 of a manipulating device 5 is fastened to the endface 3 of the component 1 and is connected to a coupling element whichis not shown in any more detail and which is integrated in the component1.

The coupling element 4 is connected to a shaft 6 of the manipulatingdevice 5 which is connected at its proximal end to a handle 7. A knob 8is moreover provided at the handle 7 and can, for example, be connectedto a core 9 which extends in a hollow space of the shaft 6 up to thecoupling element 4.

The knob 8 can be moved with respect to the handle 7, for exampledisplaced and/or rotated, to move the core 9 with respect to the shaft 6in order thus to actuate the coupling element 4 and, for example torelease the manipulating device 5 from the component 1.

A further manipulating device 5′ is connected to the component 1 atanother point via a further coupling element 4′. The furthermanipulating device 5′ likewise has a handle 7′ and a knob 8′. Thecomponent 1 cannot only be displaced, but also rotated by bothmanipulating devices 5, 5′ together which are fastened at the component1 to points spaced apart from one another.

The second manipulating device 5′ can also have a core 9′, which ismovable by means of the knob 8′, within a hollow shaft 6′.

FIG. 2 shows an exemplary implementation of a coupling device 10 at thecomponent 1 having a blind hole which has an internal thread into whicha threaded bolt 11 is screwed. The threaded bolt 11 is connected as acoupling element of the manipulating device to a core 9 which extendsthrough a hollow shaft 6 and can be rotated therein to screw thethreaded bolt 11 into or out of the threaded bore 10. The shaft 6 canthus be fastened to the component 1, which is only shown sectionally inFIG. 2, and released from it again.

Generally, a coupling element can be formed by a cut-out, in particulara bore or a groove, having an undercut or without an undercut.

It is prevented by additional spigots 50 at the shaft, which engage intocorresponding bores of the implant, that the implant also rotates on therelease of the screw connection. This moreover ensures that the implantcan also be rotatingly manipulated.

A flange 72 can also be provided in the shaft 6 and can be screwed tothe component 1 by means of the threaded bolt 11 and a head 73 of thethreaded bolt by screwing into the threaded bore 10.

FIG. 3 schematically shows a coupling element 12 of a manipulatingdevice in the form of a flat, plate-shaped thermoplastic end part atwhich a shaft 13 is engaged which forms a part of a manipulating device.The plate-shaped part 12 is connected to the wall piece 14, for examplemade in a planar fashion and forming a coupling element at the componentside, for example welded thereto, bonded thereto or manufactured in onepiece therewith as an injection molded part. The component 1 can thus bemanipulated by means of the shaft 13 until the coupling element 12 isbroken off at the component by kinking the plate 12.

For better clarity, this configuration is shown in a plan view in FIG.4, with the plate 12 and the shaft 13 being recognizable. The plate 12can be kinked and removed by pivoting in the direction of the arrows 15,16.

The attachment of the plate-shaped piece 12 in the wall 14 of thecomponent 1 forms the coupling element which is integrated there and towhich the kinkable part of the plate 12 is connected as a couplingelement of the manipulating device.

In accordance with FIG. 5, a shaft 17 is connected to a bell-shapedcoupling element 18 which is connected to the implantable component 1 bymeans of a short wire 19. The wire 19 provides that the bell 18 isseated on the component 1 and the component 1 can thus be moved by meansof the shaft 17.

The wire 19 can be turned off or torn off by a rotation of the shaft 17at its longitudinal axis or by a tilting of the bell part with a largeexpenditure of force to remove the manipulating device 17, 18 from thecomponent 1. The coupling elements 18, 19 provide a good handling of thecomponent 1 via the manipulating device as long as the connectionexists.

In FIG. 6, a coupling device is shown having a coupling element 20 whichcomprises an elastomer and which is connected to a handle 22 of amanipulating device by means of a shaft 21. The element 20 is fixed in aforce-locking manner in a bore 23 as a coupling element of animplementable component 1. For example, the element 20 can be heated andpressed into the bore 23 to establish a connection of the couplingdevice 20, 23. The manipulating device 20, 21, 22 can subsequently beremoved from the component 1 by pulling at the shaft 21. It is alsoconceivable previously to heat the coupling element 20 or to cool itconsiderably to allow it to shrink.

In FIG. 7, a coupling device is shown having a first component 1 ontowhich a coupling element in the form of a plate 24 is set, for examplewelded, soldered or bonded. The plate 24 can also be designed as anintegrated part of the component 1.

A suction cup 25 is placed on the smooth surface of the coupling element24 and can, for example, comprise an elastomer, but also a hard highlypolished plate, for example of steel. The two plates 24, 25 adhere ascoupling elements to one another in a sucking manner with a sufficientsurface quality. This is in particular the case when one of thecomponents is formed as an elastomer suction cup.

A ventilating passage 26 can be provided within the second couplingelement 25; it extends through the shaft 27 and can be aerated orevacuated from the proximal end of the manipulating device 25, 26, 27 tocouple or release the coupling device 24, 25.

In FIG. 8, a section of an implantable component 51 is shownschematically having a dovetail groove 28 or a bore having undercuts.

If it is a radially symmetrical bore having undercuts, in accordancewith FIG. 9, a tulip-like coupling element 29 having outwardly facinglatching noses can thus be inserted therein which elastically latch intothe undercuts of the bore 28. The coupling element 29 is connected to ashaft 30 of a manipulating device and can also only be pulled out of thebore 28 by sufficient pulling at this shaft 30 when a blocking element51 in the form of a cylinder is spaced apart axially from the latchingnoses 29 within a cut-out 52 in the manipulation apparatus by means ofmovement of the core 53 and thus releases an inward movement of thelatching noses. The shaft 30 is hollow to receive the core 53.

Another constellation of a coupling element 31 is shown in FIG. 10 whichis equally arranged in a bore of the implantable component 1 havingundercuts and which is substantially cylindrical with outwardly facinglatching noses of elastically bendable end regions of end fingers of thecoupling element. The coupling element 31 is also fixedly seated in thebore 28, but can be pulled out thereof by expenditure of force or bypulling in the latching noses of the coupling element 31.

FIG. 11 shows a coupling apparatus having a first coupling element 32and a second coupling element 33 which are each formed in plate-shape.The first coupling element 32 is fastened to a section of an implantablecomponent 1 by bonding, welding or other joining technique and has aplanar, smooth surface on the side remote from the component 1. Thesecond coupling element 33 is laid onto the surface and is fastenedthere, for example, by means of an adhesive, e.g. an epoxy resin oranother curable resin.

The coupling elements are thereby connected to one another and the shaft34 of a manipulating device is connected in a fixed and self-retainingmanner to the component 1 via this coupling apparatus.

The connection can be permanently established, for example, beforeintroduction of the component 1 into a patient's body.

To release the coupling connection, the epoxy resin between the couplingelements 32, 33 can be rehardened so much, for example by means of a UVradiation source 35, that it becomes brittle so that the couplingelements 32, 33 can easily be separated from one another.

Provision can, however, also be made that the coupling elements 32, 33are connected to one another by a thermoplastic adhesive which can beliquefied by irradiation, for example by a heat source, so that thecoupling can be dissolved in this manner and the manipulating device canbe removed by separation of the second coupling element 33 from thefirst coupling element 32. Ultrasonic pulses or laser beams can also beused to dissolve the coupling.

A constellation is shown in FIG. 12 in which a hollow cylindricalcomponent 1 as a coupling element has, for example, a spherical fittingsurface 54 and two conical fitting surfaces 55, 56. The complementarycone 57 can run into the fitting surface 56 parallel to the longitudinalaxis of the cylindrical component 1; the complementary bodies 58, 59 canmove radially into the other fitting surfaces. The bodies 57, 58, 59each represent coupling elements of a manipulating device and can beformed as ferromagnetic bodies, optionally as magnets, and also asswitchable electromagnets.

The fitting surfaces 54, 55, 56 can each be surrounded by ferromagneticand/or magnetized material of the component 1, as shown for the exampleof the fitting surface 56 by hatching of the magnetic region 60.

Provision can also be made that the magnetic effect of magneticallyeffective parts 61 in the interior of the component 1, for example ofparts of a pump drive or of a magnetic valve, are used for the coupling.

To facilitate a coupling of the manipulating device to the component bymeans of imaging processes, a marker body 70 integrated in the wall ofthe component or a surface coat 71 of a fitting surface 54 comprising amaterial of high density, in particular metal, preferably a preciousmetal, chromium or surgical steel, can be provided.

To release such a magnetic coupling, either a correspondingelectromagnet can be switched off or the manipulation apparatus can bemoved in a jerky manner. A demagnetization of the magnets by means of analternating field can also take place. A different alignment of themagnetic poles with respect to one another can however, also be achievedby rotating the one magnet with respect to the other so that asimplified release is made possible by the magnetic repelling forceswhich arise.

In FIG. 13, a coupling apparatus is shown having a plate 32′ which isjointed to an implantable component 1 and which has a blind bore 44having an internal thread. The plate 32′ having the blind bore 44 inthis respect represents a first coupling element of the component 1. Asecond coupling element can be connected to this first coupling elementand has a threaded bolt 45 which is connected to a core 46. The core 46extends in the hollow space of a shaft 47 which represents a part of amanipulating device and is proximally connected to a handle not shown inFIG. 13. The shaft 47 and the core 46 are connected to the couplingelement 32′ of the implantable component 1 by means of the threaded bolt44.

If the core 46 is rotated with respect to the shaft 47 via a knob at thehandle of the manipulating device, the threaded bolt 45 can hereby bescrewed into the plate 32′ or out of it or of the threaded bore 44 inorder to establish or separate the coupling depending on the situation.

In the state of an established coupling, the coupling apparatus isself-retaining, i.e. the first component 1 can easily be displaced andpositioned or rotated as desired at the handle, not shown, of themanipulating device.

The threaded bolt 47 can selectively also be replaced with a nut havingan internal thread connected to the core 46 and the threaded bore 44with a corresponding threaded bolt.

As a further embodiment, the implantable component can also have awrench flat, for example a hexagonal flat, as a coupling element towhich a complementary wrench can engage as a second coupling element. Ifthis combination is designed in a press fit, the connection isself-retaining.

Provision is advantageously made in the described coupling devices toform them at the implant at the surface not conducting blood. Anycontamination or damage to the passage conducting blood can thereby beprevented. In addition, any cut-outs, bores or the like provided are notprovided at the blood conducting passage so that dead flow regions areavoided.

As shown in FIG. 14, a combination of an inflatable hollow body, inparticular of cushion, on the one hand, and of a gripping surface, onthe other hand, can also be provided as a coupling device, for exampleat the component side.

For example, a cushion inflatable via the shaft of a manipulating devicecan be introduced into a hollow space of a component and inflated there.For this purpose, the corresponding hollow space can have an undercut.The inflatable hollow body can also be made as a torus 63, 64 and bepushed over the component 1 or a part 62 of the component and inflatedthere.

As soon as the implant has been positioned and aligned, the pressure inthe hollow body can be reduced and the coupling apparatus thusseparated.

The hollow body can be coated with an elastomer for better adhesion tothe component and to save the component surfaces.

A fluid passage 66 is in each case provided in the shaft 65 of themanipulating device for inflating and pressure reducing of the hollowbody. Beads 67, 68 can be provided at the component 1 for holding thehollow body which thus form corresponding fitting surfaces as a couplingelement at the component side.

The component can be simply positioned and aligned by a surgeon by thedifferent variants shown of a self-retaining coupling apparatus betweenan implantable component and a manipulating device without the hand ofthe surgeon having to be directly guided into the operating field. Acomparatively small access to the operating field is thereby madepossible. The connection between the instrument or the manipulatingdevice, on the one hand, and the component, on the other hand, canalready be established before the actual surgical procedure and can bedissolved after the implantation.

The manipulating device, the coupling device and the implantablecomponent can be characterized generally by the following principles ofaction as special aspects of the invention:

-   1st aspect: the provision of fixed wrench flats at the component    which cooperate with a complementary form of a coupling element;-   2nd aspect: the coupling via a force locking (clamping) by an    inflatable body or by a body of a coupling element spreadable in an    opening;-   3rd aspect: the coupling simultaneously at two points spaced apart    from one another at the component, whereby the rotatability and    tiltability is improved as a consequence of the separate    manipulation possibilities of the coupling points;-   4th aspect: the magnetic coupling of a coupling element of the    manipulating device to a magnetically active part of the implantable    component, in particular a drive unit, further particularly a pump    unit.

What is claimed is:
 1. At least one manipulating device for handling acomponent of a system for blood conveying, comprising: an implantablecomponent adapted to be implantable into a patient's body, saidcomponent also adapted to convey blood; said at least one manipulatingdevice connected to said implantable component, wherein said at leastone manipulating device is adapted to provide manipulation of theimplantable component in all spatial directions; wherein said at leastone manipulating device comprises a hollow shaft connected to saidimplantable component, and a rotatable core, wherein said rotatable corehas a threaded bolt affixed to one end, and wherein said implantablecomponent has a threaded bore adapted to selectively receive saidthreaded bolt therein; wherein where said hollow shaft connects withsaid bore said hollow shaft has a flange that is at least partiallyreceived on said implantable component, wherein said flange is adaptedto improve controllability of the implantable component.
 2. The at leastone manipulating device of claim 1, further comprising spigots on theshaft, wherein said spigots are adapted to engage with correspondingbores in the implantable component.
 3. The at least one manipulatingdevice of claim 2, wherein said spigots are adapted to manipulate theimplantable component.
 4. The at least one manipulating device of claim2, wherein said spigots are located opposite one another and on oppositesides of said bore.
 5. The at least one manipulating device of claim 2,wherein said spigots extend transversely from said flange.
 6. The atleast one manipulating device of claim 2, wherein said bolt extendsthrough an aperture in said flange.
 7. The at least one manipulatingdevice of claim 2, wherein said flange extends on either side of saidshaft.
 8. The at least one manipulating device of claim 1, wherein saidat least one manipulating device, said hollow shaft and said threadedbolt are one piece.
 9. At least one manipulating device for handling acomponent of a system for blood conveying, comprising: an implantablecomponent adapted to be implantable into a patient's body, saidcomponent also adapted to convey blood; said at least one manipulatingdevice connected to said implantable component, wherein said at leastone manipulating device is adapted to provide manipulation of theimplantable component in all spatial directions; a plate having athreaded bore therein, said plate connected to said manipulating device,wherein said at least one manipulating device comprises a hollow shaftconnected to said implantable component, and a rotatable core, whereinsaid rotatable core has a threaded bolt affixed to one end, wherein saidthreaded bore is adapted to selectively receive said threaded bolttherein; wherein where said hollow shaft connects with said bore saidhollow shaft has a flange that is at least partially received on saidimplantable component, wherein said flange is adapted to preventrotation of the implantable component when the connection to themanipulating device loosens.
 10. The at least one manipulating device ofclaim 9, wherein said manipulating device, said plate and said hollowshaft are one piece.
 11. At least one manipulating device for handling acomponent of a system for blood conveying, comprising: an implantablecomponent adapted to be implantable into a patient's body, saidcomponent also adapted to convey blood; said at least one manipulatingdevice connected to said implantable component, wherein said at leastone manipulating device is adapted to provide manipulation of theimplantable component in all spatial directions; wherein said at leastone manipulating device comprises a hollow shaft connected to saidimplantable component, and a rotatable core, wherein said rotatable corehas a threaded bolt affixed to one end, and wherein said implantablecomponent has a threaded bore adapted to selectively receive saidthreaded bolt therein, wherein spigots are on the shaft, wherein saidspigots are adapted to engage with corresponding bores in theimplantable component.
 12. The at least one manipulating device of claim11, wherein said spigots are adapted to manipulate the implantablecomponent.
 13. The at least one manipulating device of claim 11, whereinsaid spigots are located opposite one another and on opposite sides ofsaid bore.
 14. The at least one manipulating device of claim 11, whereinsaid spigots extend transversely from a flange on said shaft.
 15. The atleast one manipulating device of claim 14, wherein said bolt extendsthrough an aperture in said flange.
 16. The at least one manipulatingdevice of claim 14, wherein said flange extends on either side of saidshaft.